CONMED 00509223000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854001189), received between Feb 28, 2023 and Feb 28, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 28, 2023Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE 00509223000, 5MM ROUND BUR, LONG, CARBIDE, 5EA, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON THE DATE OF 07FEB23, WHEN IT WAS REPORTED, ¿OUR CUSTOMER USED THIS BUR WITH THE SURGAIRTOME TWO BUT DID NOT USE THE BUR GUARD. WHEN USED IN THAT STATE, THE SPHERICAL CUT PORTION AT THE TIP CAME OFF AND REMAINED IN THE BONE. ALSO, THE SHAFT BROKE IN TWO.¿. AFTER FURTHER ASSESSMENT, IT WAS REPORTED THE FRAGMENTATION STILL REMAINS IN THE PATIENT¿S BONE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE BACKUP BUR. IT WAS REPORTED THERE WAS NO PATIENT OR USER IMPACT, MEDICAL OR SURGICAL INTERVENTION. IT IS UNKNOWN IF THE PATIENT REQUIRED EXTENDED HOSPITALIZATION. THE PATIENT IS REPORTED TO BE UNDER OBSERVATION. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO FRAGMENTATION REMAINING IN THE PATIENT¿S BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16452640 ↗